Asciminib

Asciminib was originally developed by Novartis and comes in two sizes, 20mg and 40mg, to meet the treatment needs of different patients.

Asciminib was first approved for sale in the United States in January 2021, becoming the world's first approved STAMP inhibitor.

Asciminib effectively inhibits BCR-ABL1 cancer protein kinase activity by specifically targeting ABL myristoyl pocket, reducing the proliferation and spread of leukemia cells.

1.Main components

Asciminib

2.Adapt to the population

Patients with specific types of chronic myeloid leukemia (CML).

3.Medication for special populations

3.1Pregnant

There are no available data on Asciminib use in pregnant women to evaluate a drug associated risk.Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

3.2Lactation

There are no data on the presence of Asciminib or its metabolites in human milk, the effects on the breastfed child, or milk production.

3.3Females and Males of Reproductive Potential

Verify the pregnancy status of females of reproductive potential prior to starting treatment with Asciminib.

Females of reproductive potential should use effective contraception during treatment with Asciminib and for 1 week after the last dose.

3.4Pediatric Use

The safety and efficacy of Asciminib in pediatric patients have not been established.

3.5Geriatric Use

No differences in safety or efficacy of Asciminib were observed between patients 65 years of age or older compared to younger patients.

There is an insufficient number of patients 75 years of age or older to assess whether there are differences in safety or efficacy.

3.6Renal Impairment

No dose adjustment is required for patients with mild to severe renal impairment and not requiring dialysis receiving Asciminib.

3.7Hepatic Impairment

No dose adjustment is required for patients with mild to severe hepatic impairmentreceiving Asciminib.

4.Drug overdose

Drug overdose is not yet clear.

5.Drug storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).Dispense and store in the original container in order to protect from moisture.

6.Pharmacokinetics

The median (range) Tmax of Asciminib is 2.5 hours (2 to 3 hours).

from FDA,2021.10